Optimizing HIV Virologic Outcomes for Pregnant Women in Uganda

HIV Clinical Trial

— ENHANCED-SPS  

Official title:

Enhanced Viral Load Counseling and Standardized Peer Mother Support Study (ENHANCED-SPS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04122144
• Other study ID #: REC REF 2018-074
• Secondary ID: HS 2648
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2019
• Est. completion date: September 19, 2022

Study information

• Verified date: October 2019
• Source: Makerere University
• Contact: Jane Kabami, MPH
• Phone: +256776411044
• Email: kabajane[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The ENHANCED -SPS study is a before and after cluster randomized trial that will be conducted in 14 public health facilities providing HIV care in Southwestern Uganda. The study will evaluate the effectiveness of a multi-component intervention package that targets barriers to achieving optimal viral suppression among pregnant and postpartum women infected with HIV. This will be in two phases; In Phase 1 ("Before"), all 14 clinics will have a baseline assessment of standard of care VL procedures and assess the barriers and facilitators to viral suppression for a period of 3 months. In Phase 2 ("After"), 7 clinics randomized to control arm will continue to experience standard of care counseling procedures, and 7 clinics randomized to intervention will initiate the ENHANCE-PS intervention. The Phase 2 ("After") phase I will last at least 12 months.

Description:

The Investigators will test the hypothesis that the Enhanced viral load (VL) counseling and standardized peer mother support (ENHANCED-SPS) intervention will increase viral load suppression among HIV-infected pregnant and post-partum women and increase retention of mothers in care hence resulting in reduced risk of vertical transmission in south western Uganda.

Specific objectives are as follows:

1) To evaluate the effectiveness of an enhanced VL counseling and standardized peer mother support intervention on viral suppression among HIV infected pregnant women at 12 months of follow up; 2) To evaluate the effect of the enhanced counseling and peer support intervention on retention in care at 18 months postpartum follow up; The investigators will randomize 14 HIV clinics to the ENHANCED-SPS multi-component intervention vs. standard of care procedures (intervention=7 clinics and control=7 clinics,n=70 mothers/health facility) ;3) To assess the facilitators and barriers of VL and enhanced VL counseling and peer mother support intervention at 9 & 18 months of follow up.This will consider both patient and providers perspectives of the intervention implementation

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 980
• Est. completion date: September 19, 2022
• Est. primary completion date: September 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 45 Years

Eligibility

Inclusion Criteria:

1. All Pregnant women and breastfeeding mothers enrolled in the mother baby care points/HIV clinics with documented HIV infection

2. . HIV infected Pregnant women reporting for their first ANC within the study clinics or newly identified HIV positive mothers from the ANC clinics/breastfeeding

Exclusion Criteria:

3. . All women who will be critically ill and unable to communicate

4. . Those not willing to consent to participate in the study

5. . Women who will not be able to understand all information concerning the study

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• ENHANCED -SPS intervention
a) Enhanced VL counseling: Explanation of VL & Importance of VL suppression,assessment of adherence, counseling based on VL result and schedule for next VL testing and the role of VL and the MTCT risk; b).Standardized peer mother support: includes training of peer mothers on mandatory enhanced VL counseling during the routine peer counseling and education, follow up of mothers and continued adherence counseling and disclosure support and bi-weekly phone calls to mothers to provide VL counseling and follow up

Locations

Country	Name	City	State
Uganda	Jane Kabami	Kampala	Mbarara

Sponsors (3)

Lead Sponsor	Collaborator
Makerere University	Infectious Diseases Research Collaboration, Uganda, University of California, San Francisco

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral suppression	The proportion of women with HIV-1 RNA suppression at 12 months of follow up to assess the effect of the intervention	1 year
Primary	Retention in care	The proportion of women still in care at at 12 and 18 months postpartum	18 months
Secondary	Mother to child transmission rate	The proportion of HIV free children born to the HIV positive mothers enrolled in the study at 18 months of follow up.	18 months